HIV, DNA kits offer a revolution in home testing

A print ad for the first home pregnancy test to hit the market in 1977 called the product “a private little revolution.”

Decades later, technology has delivered more sophisticated testing away from the medical lab and into the consumer's bathroom or kitchen, no doctor's order required.

A test for HIV and another for personal genetics tied to disease risk offer the chance for knowledge with the swab of a cheek or a sample of saliva. While bringing convenience and privacy, experts caution that some users might not be equipped to process or interpret the results outside of a health care setting.

“This is an HIV test,” said Martin Salas, director of health education and prevention for AIDS Services Foundation of Orange County. “This is not a pregnancy test or any other form of screening.”

In July 2012, the Food and Drug Administration approved the first at-home HIV test with results in as little as 20 minutes. According to the Centers for Disease Control and Prevention, about 1.2 million people in the United States are living with HIV, and about 1 in 5 of them don't know they are infected, increasing the chance that they will spread the virus.

The OraQuick test, which is sold online and in pharmacies for about $40, requires a cheek swab and a short wait for results. OraSure Technologies, a Pennsylvania company, has sold more than 200,000 kits. Testers are advised that a positive result must be confirmed in a medical office.

Kathy Weber, senior vice president of consumer products, said sales have been a little below expectations. In September, the company began a new marketing campaign aimed at gay men and African American women, groups with a higher prevalence of HIV.

“The goal is to get more people tested,” Weber said. “We're trying to stimulate a conversation around HIV and have people talking to their partners and also to drive product awareness. Some of what we've learned over the last year in talking to consumers and doing a lot of research with them is that it's tough to just have a conversation around HIV. It's a scary topic. We could be much more effective if we put it in the context of dating and relationships and sex and life.”

Weber said users are cautioned to take the test in the right state of mind. A how-to video advises that if a person feels too anxious, a test in a doctor's office or medical clinic might be a better option. The company offers an around-the-clock, bilingual call center for consumers taking the test.

“The support system that we've put in place is fairly extensive,” Weber said.

Salas, of AIDS Services Foundation in Irvine, said he thinks the test is advisable only for the most knowledgeable, resourceful and stable of consumers. He noted that some people have shown up at the office in a state of disbelief after testing positive at home.

“We have to remind ourselves of the stigma continued to be linked to HIV infection,” he said. “Is that person's state of mind the optimal level so the person can read the result, interpret the result and what is next? Does that individual have the capacity to understand the implications?”

Last year, 2,300 people were tested at the nonprofit. Regardless of the result, all were informed in person and counseled either about treatment and support or how to remain HIV negative.

“In a medical setting we provide the information, we provide the results and we assess the psychological state of mind in order to continue with specific steps and guidelines and recommendations,” Salas said.

Personalized Medicine

In August, a Mountain View-based company called 23 and Me launched a television ad campaign touting the health benefits of genetic testing. The company name refers to the number of pairs of chromosomes in the body. So far, more than 400,000 people have been tested and most of them have agreed to participate in the company's genetic research of disease.

For $99, customers receive a kit where they spit into a tube and mail it back. The DNA is extracted and processed. Then customers receive a confidential online report that covers everything from ancestry to drug sensitivities to potential risk of 120 conditions such as Alzheimer's disease and age-related macular degeneration.

“We hope it will be a routine part of health care like a cholesterol test at some point,” company spokeswoman Catherine Afarian said. “This is information people should have in managing their health.”

The test checks for a number of inherited disorders, including those that are recessive, such as cystic fibrosis. Testing also includes three mutations for BRCA, a gene linked to breast cancer, but not the entire sequence, meaning not all mutations will be caught.

Afarian said the report alerts customers to areas where genetic research is less certain about potential risk.

“I think the vast majority of people understand that genetics are just one factor,” Afarian said. “We give them one piece of the picture regarding their overall health. It's not necessarily a diagnostic tool. Just because you have a genetic risk factor or don't, it doesn't mean you're going to get the disease.”

Afarian said customers can pick and choose what information they want to read. Reports include information on prevention and lifestyle.

“It is a really personal experience,” Afarian said. “Some people get the information back and they want to talk about every single report with their doctor, and we see other customers who say, ‘This is really interesting. I didn't know I was at risk for colorectal cancer, so I'll make sure I don't drag my feet about getting a colonoscopy.'”

Dr. Virginia Kimonis, a geneticist and pediatrician at UC Irvine, said the test can be useful, but she's also seen it cause unnecessary worry among patients.

“I did the 23 and Me,” Kimonis said. “They found that I had a high risk for heart disease. But if I had just written down my family history with a pen and paper, I would have found that myself.”

Kimonis said finding out about increased risk for heart disease or type 2 diabetes might motivate some test takers to make positive lifestyle changes.

“If they have an increased risk of heart disease, they can lose weight,” she said. “I think it's a good thing to do because it will make people more proactive and prevent disease. But it has to be done in a safe way.”

Kimonis said statistics can be difficult to interpret and that a result showing an increased risk of developing thyroid cancer, for instance, can still be extremely small. She said meeting with a genetic counselor could help users navigate any positive results in their reports.

“They get scared; they don't understand what it means,” she said. “They don't know that it's still an incredibly small chance. Most people don't really understand statistics. Most people don't have much genetics background and it's complex.”

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